Respiratory Tract Infections Clinical Trial
Official title:
Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal Virus-Like Particles (VLP) Quadrivalent Influenza Vaccine in the Elderly Population
This is a multiple sites phase II trial, randomized, observer-blind, dose ranging,
placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single
intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine
administered in elderly subjects (50 years old and more).
A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75
subjects to receive one injection of either a non-adjuvanted low, medium or high dose level
of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined
with Alhydrogel® as adjuvant or the placebo preparation (100 millimolar (mM) phosphate buffer
+ 150 mM sodium chloride (NaCl) + 0.01% Tween 80)
This study will use cohort staggering (slow enrollment) for 3 non-adjuvanted dose levels
(low, medium, high dose level of VLP per strain), 2 adjuvanted dose levels (low or high dose
level of VLP per strain) and a placebo-controlled group divided in 3 cohorts:
- Cohort 1: Approximately one hundred and thirty-eight (138) subjects will be randomized
and dosed as follows: seventy-five (75) subjects with the lowest non-adjuvanted dose of
the quadrivalent VLP vaccine, nineteen (19) subjects with the medium non-adjuvanted dose
of the quadrivalent VLP vaccine, nineteen (19) subjects with the lowest adjuvanted dose
of the quadrivalent VLP vaccine and twenty-five (25) subjects with a placebo. The 7-day
safety data after the immunization will be collected by the clinical staff and will be
reviewed by the Data and Safety Monitoring Board (DSMB). The DSMB consisting of the PIs,
the Sponsor's Medical Officer and 3 external medical advisors (voting members); the
members will determine if the clinical sites are allowed to continue with the
immunization of the second cohort.
- Cohort 2: Approximately one hundred and seventy-five (175) subjects will be randomized
and dosed as follows: fifty-six (56) subjects with the medium non-adjuvanted dose
quadrivalent VLP vaccine, fifty-six (56) subjects with the lowest adjuvanted dose
quadrivalent VLP vaccine, nineteen (19) subjects with the highest adjuvanted dose
quadrivalent VLP vaccine, nineteen (19) subjects with the highest non-adjuvanted dose
quadrivalent VLP vaccine and twenty-five (25) subjects with a placebo. The 7-day safety
data after the immunization will be collected by the clinical staff and reviewed by the
DSMB prior to allowing immunization of the third cohort.
- Cohort 3: Approximately one hundred and thirty-seven (137) subjects will be randomized
and dosed as follows: fifty-six (56) subjects with the highest adjuvanted dose,
fifty-six (56) subjects with the highest non-adjuvanted dose and twenty-five (25)
subjects with a placebo.
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